APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia
January 07 2021 - 7:10AM
Apollomics, Inc., an innovative biopharmaceutical company committed
to the discovery and development of mono- and combination- oncology
therapies, and GlycoMimetics (Nasdaq: GLYC), today announced
APL-106 (uproleselan) has been granted Breakthrough Therapy
Designation (BTD) from the China National Medical Products
Administration (NMPA) Center for Drug Evaluation (CDE) for the
treatment of relapsed/refractory acute myeloid leukemia (AML).
“This Breakthrough Therapy Designation for
APL-106 reinforces its potential and is an important regulatory
milestone for Apollomics as we prepare to initiate our clinical
development work in China for patients suffering from AML,” said
Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive
Officer. “AML is an aggressive disease and relapsed/refractory
patients have an extremely poor prognosis. We look forward to
initiating our Phase 3 bridging study this year and working with
the CDE on a potentially accelerated clinical development program
to address this important patient need.”
In September 2020, the NMPA CDE granted
Investigational New Drug (IND) approval for APL-106 enabling the
initiation of a Phase 1 pharmacokinetics (PK) and tolerability
study and includes acceptance of a Phase 3 bridging study of
APL-106 in combination with chemotherapy in relapsed/refractory
AML.
The BTD is part of the revised Drug Registration
Regulation that became effective in July 2020 in China. The
BTD is designed to expedite the development and review of therapies
that are being developed for treatment of serious diseases for
which there is no existing treatment or where preliminary evidence
indicates significant advantages of the therapy over available
treatment options.1
About Uproleselan (APL-106)
Discovered and developed by GlycoMimetics,
uproleselan (APL-106) is a late clinical-stage, potentially
first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’
pro le’ sel an) is designed to block E-selectin (an adhesion
molecule on cells in the bone marrow) from binding with blood
cancer cells as a targeted approach to disrupting well-established
mechanisms of leukemic cell resistance within the bone marrow
microenvironment. In 2017, the U.S. Food and Drug Administration
granted Breakthrough Therapy Designation to uproleselan for
treatment of adults with relapsed or refractory AML. Apollomics
licensed APL-106 from GlycoMimetics in January 2020 to develop and
commercialize APL-106 in Mainland China, Hong Kong, Macau and
Taiwan, also known as Greater China.
About Acute Myeloid Leukemia
(AML)
Acute Myeloid Leukemia (AML) is a cancer of the
blood and bone marrow. It is an aggressive disease that causes the
bone marrow to produce immature cells that are unable to carry out
their normal function and develop into leukemic white blood cells
called myeloblasts. In the U.S., there are approximately 20,000 new
cases of AML each year and a 5-year survival rate of 28.7%.2 The
annual incidence of new cases of AML in China is 21,600, and
relapsed/refractory AML has an extremely poor prognosis.3
About Apollomics, Inc.
Apollomics, Inc. is an innovative
biopharmaceutical company committed to the discovery and
development of mono- and combination- oncology therapies to harness
the immune system and target specific molecular pathways to
eradicate cancer. The company’s existing pipeline consists of
several development-stage assets, including novel, humanized
monoclonal antibodies that restore the body’s immune system to
recognize and kill cancer cells, and targeted therapies against
uncontrolled growth signaling pathways. For more information,
please visit www.apollomicsinc.com.
About GlycoMimetics,
Inc.
GlycoMimetics is a biotechnology company
with two late-stage clinical development programs and a pipeline of
novel glycomimetic drugs, all designed to address unmet medical
needs resulting from diseases in which carbohydrate biology plays a
key role. GlycoMimetics' drug candidate, uproleselan, an
E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial
as a potential treatment for AML and is being evaluated across a
range of patient populations including a Company-sponsored Phase 3
trial in relapsed/refractory AML under Breakthrough Therapy
designation. Rivipansel, a pan-selectin antagonist, is being
explored for use in treatment of acute VOC in sickle cell
disease. GlycoMimetics has also completed a Phase 1
clinical trial with another wholly-owned drug candidate, GMI-1359,
a combined CXCR4 and E-selectin
antagonist. GlycoMimetics is located in Rockville,
MD in the BioHealth Capital Region. Learn more
at www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including those relating to the planned or potential
clinical development of uproleselan and engagement with regulatory
authorities, as well as the potential benefits and impact of the
product candidate. Actual results may differ materially from those
described in these forward-looking statements. For a further
description of the risks associated with these statements as they
relate to GlycoMimetics, as well as other risks
facing GlycoMimetics, please see the risk factors described in
the GlycoMimetics annual report on Form 10-K filed with
the U.S. Securities and Exchange Commission (SEC)
on February 28, 2020, and other
filings GlycoMimetics makes with the SEC from
time to time. Forward-looking statements speak only as of the date
of this release, and GlycoMimetics undertakes no
obligation to update or revise these statements, except as may be
required by law.
1China Drug Registration
Regulation: http://www.gov.cn/gongbao/content/2020/content_5512563.htm2National
Cancer Institute Surveillance, Epidemiology, and End Results (SEER)
Program3Yang Xiaofeng, Zhang Sufen, Zhang Qingyuan. Practical
Therapeutics of Hematological Diseases[M]. Military Medical Science
Press, 2008.
Apollomics Contact Information: |
|
|
Investor Contact: |
|
Wilson W. Cheung |
|
Chief Financial Officer |
|
(650) 209-4436 |
|
wcheung@apollomicsinc.com |
|
|
|
China Media Contact: |
|
Porda Havas International Finance Communications
Group |
Kelly Fung |
Phoenix Fung |
General Manager |
Assistant Vice President |
(852) 3150 6763 |
(852) 3150 6773 |
kelly.fung@pordahavas.com |
phoenix.fung@pordahavas.com |
|
|
U.S. Media Contact: |
|
Remy Bernarda |
|
Corporate Communications |
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(415) 203-6386 |
|
remy.bernarda@apollomicsinc.com |
|
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GlycoMimetics Contact
Information: |
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Investor Contact: |
|
Shari Annes |
|
650-888-0902 |
|
sannes@annesassociates.com |
|
|
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Media Contact: |
|
Jamie Lacey-Moreira |
|
410-299-3310 |
|
jamielacey@presscommpr.com |
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